Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Advanced Instruments, Inc. — Predicate Candidate Screening

16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

78 daysmedian FDA review time
245 days90th percentile
16clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K152776Glocyte Automated Cell Counter SystemAdvanced Instruments, Inc.2016-05-272450
K120631PATIENT MONITORAdvanced Instruments, Inc.2012-05-25850
K112465VITAL SIGNS MONITORAdvanced Instruments, Inc.2011-09-14190
K965036THE ADVANCED OSMOMETER (3900)Advanced Instruments, Inc.1997-02-20650
K962056ADVANCED MICRO-OSMOMETER MODEL 3300Advanced Instruments, Inc.1996-07-11440
K930526INTERMITTENT COMPRESSION SYSTEM MODEL 5000Advanced Instruments, Inc.1993-11-182890
K925970MODEL 3D3 OSMOMETERAdvanced Instruments, Inc.1993-07-092260
K911092OSMOMETER MODEL 2400Advanced Instruments, Inc.1991-05-22720
K873642OSMOMETER MODEL 110Advanced Instruments, Inc.1987-10-20410
K863516ELECTRONIC METAL LOCATOR MODEL MD-1Advanced Instruments, Inc.1986-09-30210
K842784CEREGROTRACAdvanced Instruments, Inc.1985-01-101770
K840385VIDEO PRINTAdvanced Instruments, Inc.1984-02-27280
K832783MICRO-SAMPLE OSMOMETER 3M0Advanced Instruments, Inc.1983-11-281040
K811840BILIRUBINOMETERAdvanced Instruments, Inc.1981-07-15140
K790608BL BILIRUBINOMETERAdvanced Instruments, Inc.1979-06-15780
K790611OSMOMETER MODEL 3W11Advanced Instruments, Inc.1979-06-15780

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda